Note: The policies, guidelines, terms, and conditions stated in
this announcement may differ from those used by the NIH.

Announcement
Type
This
Funding Opportunity Announcement (FOA) is a “Re-Issue” of RFA-FD-08-010

Program Announcement
(PA) Number: PAR-09-203

NOTICE: Applications submitted in response to this
Funding Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424
(R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.

This re-issued
announcement provides for the change in the funding level of the grant program.

This grant announcement is intended to encourage the development of an
Innovative Food Defense Program within each State or County and to provide
funding for such efforts. Grant funding is available to State, local, and
tribal agencies.

Purpose.This Funding
Opportunity Announcement (FOA), issued by the Food and Drug Administration
under Grant mechanism (R18), is to solicit applications from institutions/
organizations that propose to develop Innovative Food Defense programs
within the United States. The program should encompass 3 broad strategies in its food defense
activities (1) Awareness
(Prevention/Preparedness); (2) Response;
and (3) Recovery.

Mechanism of Support. This FOA will utilize the R18 grant mechanism.

Funds Available and Anticipated Number of Awards.Under this
announcement, the FDA anticipates providing approximately $250,000 in
grant funds in support of this program in Fiscal Year 2009. It is
estimated that about 4 grants at the level requested, but not exceeding
$62,500 in total costs (direct and indirect) each for one (1) year of
support, will be awarded.

Budget and Project Period. The length of support will be for one (1)year from date
of award.

Eligible Project Directors/Principal Investigators
(PDs/PIs). Individuals with the skills, knowledge, and
resources necessary to carry out the proposed project are invited to work
with their institution/ organization to develop an application for
support. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are always encouraged to apply for FDA support.

Number of PDs/PIs. Only one PD/PI may be
designated on the application.

Number of Applications. Applicants may submit
more than one application, provided each application is programmatically
distinct.

Resubmissions. Applicants are not permitted to submit a resubmission
application in response to this FOA.

The Food and Drug Administration (FDA or Agency) is announcing the
availability of grant funds for the support of innovative food defense projects.

FDA will support projects covered by this notice under
Title XVII of the Public Health Service Act, Section 1702 (42 U.S.C. 300u-1),
Section 1004 of the Food and Drug Administration Amendments Act of 2007 (21
U.S.C. 2104) and, in addition, Section 909 of the Federal Food, Drug,
and Cosmetic Act (as amended by the Bioterrorism Act of 2002) (21
U.S.C. 399). FDA's project program is described in the Catalog of Federal
Domestic Assistance, No. 93.103, and applicants are limited to food safety regulatory agencies of State, local, and tribal governments. Internet viewers should
proceed to “Publications”.

The Public Health Service (PHS) strongly encourages all
award recipients to provide a smoke-free workplace and to discourage the use of
all tobacco products. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Background

Food defense is a term used to describe activities
associated with protecting the nation’s food supply from intentional
contamination. The Food and Drug Administration has adopted 3 broad strategies
that encompass its food defense activities:

(2) Response: Develop the capacity
for a rapid coordinated response to a food borne terrorist attack; and

(3) Recovery: Develop the capacity
for a rapid coordinated recovery from a food borne terrorist attack.

Stakeholders must determine how to most effectively apply
resources within this continuum of activities to best protect the food supply
chain and consumers. With regard to prevention and preparedness tools and
information, the FDA has provided numerous documents, tools, links and
references on the Center for Food Safety and Applied Nutrition’s (CFSAN)
website at www.cfsan.fda.gov/fooddefense .

As we continue to move forward in meeting our food defense
goals by increasing preparedness, developing response plans, and ensuring we
have the tools to facilitate recovery, we must also integrate these approaches
into our existing food safety infrastructure. The overlap between food safety
(unintentional contamination) and food defense (intentional contamination) is
extensive and the pool of resources available is often the same. Food safety
and food defense are ongoing issues and it is critical that these programs be
integrated to the maximum extent possible in order to ensure the most efficient
use of resources as well as to optimize response to an event. FDA is committed
to this approach in order to make optimal use of both human and financial
resources to protect public health. As a result, FDA and State field forces
may weave components of food defense awareness and education into food safety
inspections. The FDA encourages other stakeholders to consider the
possibilities of incorporating food defense ideas into their food safety
related programs.

FDA has relied on the States assisting with these
activities through formal contracts, partnership agreements, and other
arrangements. Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, the demands on both the agency and the States have
increased. Procedures need to be reviewed and innovative changes
need to be made. These changes should increase effectiveness and efficiency and
conserve resources. CFSAN will continue to support fooddefense programs by providing high quality, science-based work that result in
maximizing consumer protection. FDA believes that these grants will be able to
generate significant innovative projects and products that will benefit State and local governments, FDA, the industry, and the general public in the
area of food defense, just as past awards have benefited all stakeholders in
food safety. It is anticipated that innovativefood defense
programs and concepts that are developed at the State and local levels could
enhance programs that are developed at the Federal level. To view past
innovative food safety / food defense awards that have been generated out of
this work you can view the ORA Web site at www.fda.gov/ora/fed_state/Innovative_Grants.html.

Project Goals, Definitions, and Examples

The specific goal of this program is to generate products
that complement, develop, or improve State and local food defense programs and
which may then be applied to food defense programs nationwide. Examples of food defense projects are the ALERT / FIRST Food Defense Awareness Initiatives; Food Defense
Surveillance Assignments (FDSA); Food Emergency Response Network (FERN: federal
and state laboratories); and the Strategic Partnership Program Agroterrorism
(SPPA) Initiative. Applications that address food defense projects and fulfill
the following specific project objectives will be considered for funding.

Each application must address only one project.
Applicants may apply for more than one project area, but must submit a separate
application for each project. If an applicant should receive a fundable score
on more than one topic area only the application with the highest score will be
awarded. These grants are not to be used to fund or conduct food inspections for food safety regulatory agencies. No more than 10% of the total award can
be used to conduct food safety/food defense exercises. Food Safety agencies
may subcontract up to 25% of the award to educational institutions for
assistance with developing food defense awareness education projects and
materials and training.

There are five (5) key project areas identified for this
effort:

1.Innovative
Food Defense Plan Integration

One key project area is the development of innovative
template food defense plans and associated programs that could be integrated
with established food safety programs; including continuous improvement plans
for the protection of various food establishments in order to improve food
defense effectiveness and efficiency. Innovative food defense programs and
methodology projects must propose to effect factors that contribute to awareness,
preparedness, early response, and recovery in all, or a segment of, food industry programs. For example, projects could address key elements from the ALERT / FIRST
Initiatives. The ALERT / FIRST initiatives are derived from the FDA Food
Security Guidance documents written for specific segments of the food
industry. These proposals should focus on providing efficient and effective
food defense awareness communications and/or have an effect on factors that
contribute to a potential intentional food contamination. Information relative
to the ALERT / FIRST initiatives can be found at www.cfsan.fda.gov/fooddefense .

2.Education and Awareness
Information Dissemination

Another key project area is the development of innovative
food defense awareness education projects and materials for State and local food safety and food defense regulatory officials. They:

should foster consistency and uniform application of State and local
food regulations

should be reproducible by other State and local food safety regulatory agencies

may incorporate concurrent education of both State and local food safety and food defense regulatory agencies and the food industry

must be consistent with the ALERT / FIRST Initiatives messages.

3.Innovative Food Defense
Training

FDA recognizes that there are a number of new technologies
and methods for distance learning and training that may be applicable to the
food industry and relevant stakeholders in relation to food defense. Innovative
food defense training should:

train state and local officials to identify, in a general sense,
potential risks in relation to food defense in food industry
establishments

train state and local officials to encourage food defense awareness
in the employees and management of food industry establishments

help ensure that all stakeholders will have an increased awareness
of the threat of intentional contamination of the US food supply

educate relevant stakeholders to understand their unique
responsibilities in reducing the risk of intentional contamination of the
food supply

be consistent with the ALERT / FIRST initiatives messages.

4. Information
Technology / Database Development

Using current technology is obviously important in
facilitating necessary communication, coordination, and information sharing
during the response to and recovery from a food emergency. To that end, the
focus of this project should be on:

the creative/novel use of existing technologies; or

to the extent possible, the development of information sharing
technologies; and/or

developing a database to assist other food regulators to be able to
view, share, post, and observe the process of the response to and recovery
from the incident.

5.Vulnerability
Assessments using CARVER+Shock Software Tool

The FDA is interested in state and local food system
regulating agencies use of the CARVER+Shock software tool to conduct
vulnerability assessments (VAs). Utilizing the CARVER+Shock software to conduct
these VAs will result in the identification of vulnerabilities within the
farm-to-table continuum and potential mitigation strategies. Sharing the
vulnerability and mitigation strategies attained during these VAs will assist
the FDA in targeting educational and awareness campaigns, to decrease the
likelihood of an intentional contamination event on the food supply. Sensitive
data shall be shared through the Department of Homeland Security’s Protected
Critical Information Infrastructure (PCII) program. These VA’s should not be misconstrued as to replace the need
for traditional food safety inspections. Additional information on
CARVER+Shock is available at www.cfsan.fda.gov/fooddefense .

This
FOA will use the R18 Grant award mechanism. Under this mechanism, the Project Director/Principle Investigator
(PD/PI) will be solely responsible for planning, directing, and executing the
proposed project.

The total project period for an application requesting
support may not exceed one (1) year.

Under this
announcement, the FDA anticipates providing
approximately $250,000 in support of this program in Fiscal Year 2009. It is
anticipated that at least four (4) awards will be made, not to exceed $62,500
in total costs (direct plus indirect) per award, per year. The length of
support will be for one (1) year from date of
award. The number of grants funded will depend on the quality of the
applications received and the availability of Federal funds to support the
grant. Grant money may not be used to fund food inspections.

Because
the nature and scope of the proposed activities will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. The total amount awarded and the number of awards will depend upon
the number of applications, quality, duration, and cost of the applications
received and the availability of funds.

This grant program is only available to State, local, and
tribal government food regulatory agencies. (See SPOC requirements stated in
section IV.A of this document).

Grantees
with active grant applications under the Innovative Food Defense Program are
not eligible to apply under this FOA.

1.B.
Eligible Individuals

Any individual(s) with the
skills, knowledge, and resources necessary to carry out the proposed project as
the PD/PI is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for FDA support.

These grants are available to State, local, and tribal governments and
MUST have national implications or applications that can enhance Federal,
State, and local food regulatory programs and are likely to impact food defense
preparedness, response, and/or recovery. At the discretion of FDA, successful
project formats will be made available to interested Federal, State, local, and
tribal food safety regulatory agencies. Only one grant will be awarded per
State per year. States are urged to collaborate between agencies, and other
food and agriculture sector stakeholders, to submit single applications.

Resubmissions: Applicants are not
permitted to submit a resubmission application in response to this FOA.

Renewals: Renewal applications
will be permitted for this FOA.

Number of Applications: Applicants may
submit more than one application, provided each application is programmatically
distinct.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and
AOR/SO need separate accounts in the NIH eRA Commons since both are authorized
to view the application image.

Several of the steps of
the registration process could take four weeks or more. Therefore, applicants
should immediately check with their business official to determine whether their
organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA); although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the “Credential” log-in
field of the “Research & Related Senior/Key Person Profile” component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

In order to expedite the
review, applicants are requested to notify the FDA Grants Management Team by email (gladys.melendez-bohler@fda.hhs.gov)when the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application and the Grants.gov grant tracking number.

3.C.
Application Processing

Do not send applications to the Center
for Scientific Research at NIH. Any application sent to NIH that is then
forwarded to FDA, and not received in time for orderly processing, will be deemed unresponsive
and returned to the applicant.

Applications may be submitted on or
after the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application
due date(s). (See Section IV.3.A. for all dates.) If an application
is not submitted by the due date(s) and time, the application may be delayed in
the review process or not reviewed.

Once an application package has been
successfully submitted through Grants.gov, any errors have been addressed, and
the assembled application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the application
image to determine if any further action is necessary.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the application
was lost or did not transfer correctly during the submission process, the
AOR/SO will have the option to “Reject” the application and submit a
Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that warnings
are applicable to your application and need to be addressed now. Remember,
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon receipt, applications will be evaluated for
completeness by the FDA. Incomplete and non-responsive applications will not be
reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
the application status in the Commons.

The
FDA will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The FDA will not accept any application that
is essentially the same as one already reviewed.

Intergovernmental review
applicants are limited to one State government agency per State. Applications
submitted under this program are subject to the requirements of Executive Order
(E.O.) 12372.

The regulations issued under EO 12372 also apply to this
program and are implemented through the DHHS regulations at 45 CFR part 100.
Executive Order 12372 sets up a system for State and local government review of
applications for Federal financial assistance. Applicants (other than
federally recognized Indian tribal governments) should contact the State’s
Single Point of Contact (SPOC) as early as possible to alert them to the
prospective application(s) and to receive any necessary instructions on the
State’s review process. A current listing of SPOCs is included in the
application kit. The SPOC should send any State review process recommendations
to the FDA Grants Management Office address listed above. The due date for the
State process recommendations is no later than 60 days after the deadline date
for the receipt of applications. The FDA does not guarantee availability to
accommodate or explain SPOC comments that are received after the 60 day
cut-off. A current listing of SPOCs can be found at www.whitehouse.gov/omb/grants/spoc.html

Applications may be submitted on or after the opening date
and must be successfully received by Grants.gov no later than 5:00 p.m. local
time on the application submission/receipt date(s). If an application is not
submitted by the receipt date(s) and time, the application will not be
reviewed.

Upon receipt, applications will be evaluated for
completeness and incomplete applications will not be processed or evaluated.

Applicants are reminded that failure to include all
required documents as part of the application may result in an application
being considered incomplete or non-responsive.

Applicants are strongly encouraged to contact FDA to
resolve any questions regarding criteria prior to submission of their
application. All questions of a technical or programmatic nature must be
submitted to the FDA program staff. All questions of an administrative or
financial nature must be submitted to the Grants Management Staff.

A copy of the complete FOA can also be viewed on the
Grants.gov website along with the funding application package. A copy of the
full FOA can be obtained from the Program or Grants Management contact list
under “Contacts” in this FOA once the FOA is published.

Several additional
separate actions are required before an applicant institution/organization can
submit an application.

The
following instructions are to be used in conjunction with application packet
instructions:

Performance
Site Locations: Enter the site of the
lab or office as the Performance Site.

Senior/Key
Person: Personnel are defined as the Project
Director (PD)/Principal Investigator (PI) and those responsible for planning
and implementing the project. Attach biographical sketches for the PD/PI and
key personnel.

Budget
Information: Enter the direct costs
requested. Provide a narrative budget justification for each proposed personnel
position, including role and proposed level of effort, and for each item of
cost requested.

Work
Plan/Project Narrative: Submit one
attachment, which may not exceed 15 pages. In the “Work Plan” (uploaded as
attachment #5) section of the application, describe the objectives and specific
program arrangements.

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

PHS398
Research Plan Component Sections

Page
limitations of the PHS 398 Research Plan component must be followed as outlined
in the SF424 (R&R) Application Guide. While
each section of the Research Plan component needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits.
All attachments must be provided to FDA in PDF format, filenames must be
included with no spaces or special characters, and a .pdf extension must be
used.

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, incorporating "Just-in-Time" information concepts.

Do not use the Appendix to circumvent the page limitations of
the Research Plan component. An application that does not comply with the
required page limitations may be delayed in the review process.

Resource Sharing
Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not
Applicable

Genome Wide Association Studies
(GWAS). Not Applicable

Section V. Application Review Information

1. Criteria

Only
the review criteria described below will be considered in the review process.

All applications submitted in response to this FOA will
first be reviewed for responsiveness by grants management and program staff.

Responsive applications
will be reviewed and evaluated for programmatic merit by an Ad Hoc panel of
experts in the subject field of the specific application. Applications will be
considered for funding on the basis of their overall programmatic merit as
determined through the review process. Other award criteria will include
availability of funds and overall program balance in terms of geography. Final
funding decisions will be made by the Commissioner of Food and Drugs or his or
her designee.

2.
Review and Selection Process

Applications that are complete and responsive to
this FOA will be evaluated for programmatic merit by an
appropriate peer review group convened by the FDA
Office of Regulatory Affairs and in accordance with FDA peer review procedures,
using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score;

Receive
a written critique.

This
award will include special terms and conditions that differ from the agency’s
usual terms and conditions. See also Section IV.5. “Funding Restrictions”.

Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following
will be considered in making funding decisions:

Programmatic
merit of the proposed project as determined by peer review.

Availability
of funds.

Relevance
of the proposed project to program priorities.

The goal of the FDA is to
protect the public health by ensuring the safety, efficacy, and security of
human and veterinary drugs, biological products, medical devices, our nation’s
food supply, cosmetics, and products that emit radiation. The FDA also may
advance the public health by helping to speed innovations that make medicines
and foods more effective, safer, and more affordable; and helping the public
get the accurate, science-based information they need to use medicines and
foods to improve their health.

In their written critiques, reviewers will be
asked to comment on each of the following criteria in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, and weighted as appropriate for each
application. Note that an application does not need to be strong in all
categories to be judged likely to have major impact and thus deserve a
meritorious priority score. For example, an investigator may propose to carry
out important work that by its nature is not innovative but is essential to
move a field forward.

Applications will be
given an overall score and judged based on all of the following criteria:

(1) Application budgets must remain within the $62,500 cap
for combined direct and indirect costs. Applications exceeding this dollar
amount will be returned as nonresponsive; (2) Applications must provide, in
DETAIL, a sound rationale and appropriate grant design to address the
objectives of the RFA; (3) the project MUST be generic enough in nature to be
used by other State, local, and tribal food regulatory agencies; (4)
applications must include a detailed explanation of the desired goals and
outcomes of the project; (5) applications must include a full description of
the project design, a detailed implementation plan, methods of execution, and a
timeline for completion; (6) applications must include a detailed description
of measures of effectiveness and a description of the source documents or data
collection methods for establishing the baseline for measurement; and (7)
applications must address the adequacy of facilities, equipment, databases, and
support services and the expertise of project staff needed for the project.

Significance: Does this initiative address an important
problem? If the aims of the application are achieved, how will food safety knowledge
be advanced? What will be the effect of this initiative on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field?

Approach: Are the conceptual framework, design, and
activities adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational
structure, consistent with and justified by the aims of the project and the
expertise of each of the PDs/PIs?

Innovation: Is the proposed project original and
innovative? For example: Does the proposal address an innovative hypothesis or
critical barrier to progress in the field? Does the proposal develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?

Investigators: Are the
PD(s)/PI(s) and other key personnel appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other staff? Do (es) the PD(s)/PI(s) and
respective team bring complementary and integrated expertise to the conference
(if applicable)?

Environment: Do(es) the environment(s) in which
the project will take place contribute to the probability of success? Do the
proposed activities benefit from unique features of the stakeholder environment,
or subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support?

2.A.
Additional Review Criteria

In addition to
the above criteria, the following items will continue to be considered in the
determination of programmatic merit and the rating:

2.B.
Additional Review Considerations

Budget and
Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.

Previous
Experience: Is there previous
experience with the organization/or the principal investigator in similar
undertakings? If so, what?

Review and Selection Process: All applications submitted in response to this
FOA will first be reviewed for responsiveness by grants management and program
staff.

2.C. Resource Sharing
Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data
Sharing Plan. Not
Applicable

Sharing
Model Organisms. Not Applicable

Genome
Wide Association Studies (GWAS). Not Applicable

3.
Anticipated Announcement and Award Dates

The successful
applicants will receive notice of pending award about two weeks after review of
applications through the Grants Management contact.

Section
VI. Award Administration Information

1.
Award Notices

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement (written
critique) via the NIH eRA Commons.

A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk.

2. Administrative and National Policy Requirements

FDA will support
projects covered by this notice under Title XVII of the Public Health Service
Act. , Section 1702 (42 U.S.C. 300u-1), Section 1004 of the
Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104) and, in
addition, Section 909 of the Federal Food, Drug, and Cosmetic Act
(as amended by the Bioterrorism Act of 2002) (21 U.S.C. 399).

All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the DHHS Grants Policy Statement. The DHHS Grants
Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm The grants will be subject to all policies
and requirements that govern the Grant Programs of the PHS, including the
provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92.

Term and Condition will be incorporated into
the award statement and will be provided to the PDPI(s) as well as to the
appropriate institutional official, at the time of award.

Awardees have primary authorities and responsibilities
to define objectives and approaches, and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of their work.

An agency Program Official or Center Program
Director/Project Officer will be responsible for the normal technical and
programmatic stewardship of the award and will be named in the NoA.

A mid-year
Progress Report is also required no later than 180 days after the award and
beginning of the budget period.The mid-year Progress Report should contain a description of
activities covering a six-month period, as well as all criteria listed in the
previous paragraph.

A final Progress Report of the
outcomes of the grant and a final Financial Status Report (FSR) (SF-269) are
required within 90 days of the expiration date of the project period as noted
on the Notice of Grant Award. An original and two copies of each report shall
be submitted to FDA’s Grants Management Office (address below). The report
should include full written documentation of the project, copies of any
results, materials, and project deliverables, as described in the grant
application, and an analysis and evaluation of the results of the project.
The documentation must be in a form and contain sufficient detail such that
other State and local food safety regulatory agencies could reproduce the final
project.

Program monitoring of recipients will
be conducted on an ongoing basis and written reports will be reviewed and
evaluated by the project officer. Project monitoring may also be in the form of
telephone conversations between the project officer/grants management
specialist and the principal investigator and/or a site visit with appropriate
officials of the recipient organization. The results of these monitoring
activities will be recorded in the official file and may be available to the
recipient upon request.

A Request for a
Non-Competing Continuation Grant Progress Report (PHS 2590) with specific
reporting instructions will be sent to Grantees two to three months prior to
the start of the next budget period by the ORA/Project Officer.

A Financial Status Report
(FSR) is required no later than 90 days after the end of each budget period.
A final progress report, invention statement, and Financial Status Report are
required when an award is relinquished, when a recipient changes institutions,
or when an award is terminated.

Section VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

URLs in FDA Grant Applications or
Appendices:
All applications and
proposals for FDA funding must be self-contained within specified page
limitations. Unless otherwise specified in this solicitation, internet
addresses (URLs) should not be used to provide information necessary for the
review because reviewers are under no obligation to view the Internet
sites.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

The
PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law
103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

Authority and Regulations:
FDA will
support projects covered by this notice under Title XVII of the Public Health
Service Act, , Section 1702 (42 U.S.C. 300u-1), Section 1004 of the
Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104) (providing
in pertinent part that the Secretary may "provide to a State, for
planning, developing, and implementing . . . a food safety program .
. . (3) financial and other assistance," 21 U.S.C. 2104(b)) and, in
addition, Section 909 of the Federal Food, Drug, and Cosmetic Act
(as amended by the Bioterrorism Act of 2002) (21 U.S.C. 399) (providing
that the Secretary "is authorized to make grants to States,
territories, and Indian tribes . . . that undertake examinations,
inspections, and investigations, and related activities under section 702 [of
the Act].") Further, 31 U.S.C. 6304 directs FDA to use grant
agreements in transferring funds to the States for legally
authorized, public purposes. This project will governed by applicable federal
regulations, including those found at 42 CFR 52 and at 45 CFR Parts 74 and 92.

This
program is described in the Catalog
of Federal Domestic Assistance (CFDA 93.103) at http://www.cfda.gov/ and is subject to the
intergovernmental review requirements of Executive Order 12372.

Access to Research
Data through the Freedom of Information Act:
The Freedom of Information Act, 5 U.S.C. 552,
provides individuals with a right to access certain records in the possession
of the Federal government. The government may withhold information pursuant to
the exemptions and exclusions contained in the act. The exact language of the
exemptions can be found in the act. Additional guidance on the exemptions and
how they apply to certain documents can be found in the HHS regulations
implementing the FOIA (45 CFR Part 5). Also see the HHS Web site http://www.hhs.gov/foia/.

Data included in the application
may be considered trade secret or confidential commercial information within
the meaning of the Freedom of Information Act (5 U.S.C. 552) and FDA's statute
and implementing regulations (21 CFR 20.61). FDA will
protect trade secret or confidential commercial information to the extent
allowed under applicable law.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.